A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients of any age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of </= 2, with a life expectancy of >/= 3 months, non-pregnant with an acceptable contraception in premenopausal women. Patients must be >4 weeks since prior radiation or prior surgery and at least 1 month post other chemotherapy.
Contraindications to angiography and selective visceral catheterization
Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs
Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels)
Significant extrahepatic disease representing an imminent life-threatening outcome
Severe liver dysfunction or pulmonary insufficiency
Active uncontrolled infection
Significant underlying medical or psychiatric illness
Patients will be excluded: if they have a co-morbid disease or an acute or chronic condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.